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Neuronix Ltd has announced that topline results from its recently completed multinational, randomized clinical trial of the neuroAD Therapy System for patients with mild to moderate Alzheimer’s disease (AD) were so positive it will be seeking regulatory clearance from the US Food and Drug Administration (FDA).

If the FDA ultimately agrees, it would mark the agency’s first time approving a medical device for treating AD. The noninvasive system combines transcranial magnetic stimulation and cognitive training “to concurrently target brain regions affected by Alzheimer’s disease,” the company explains, adding that it can also be used with other pharmacologic and nonpharmacologic treatments.

The 131-patient trial began in 2013 and was conducted in 10 centers in the United States and in Israel, which is where Neuronix is headquartered.

neuroAD Therapy System
Findings at the 6-week follow-up showed that patients who received 6 weeks of treatment with the device had significantly better scores on the AD Assessment Scale-Cognitive Subscale test than those who received placebo/sham device with sham cognitive exercises (primary outcome). They also had positive safety outcomes.

Full trial results are scheduled to be presented during a late-breaking news session December 9 at the Clinical Trials on AD meeting in San Diego, California.

In a press release, Alvaro Pascual-Leone, MD, PhD, chief of the Cognitive Neurology Division at Beth Israel Deaconess Medical Center in Boston, Massachusetts, one of the study sites, called the new device an exciting breakthrough for the field.

“While there is still no cure for Alzheimer’s disease, neuroAD is a non-invasive option, with minimal side effects, which has the potential to help patients maintain their cognitive abilities and the independence that so many of us take for granted,” said Dr Pascual-Leone.

“After years of research and development, and completing several prior successful clinical trials, this recent pivotal multicenter study…provides additional evidence that [the system] offers an important additional potential benefit to patients with Alzheimer’s disease,” said company CEO Eyal Baror in the same release.

The device had already been accepted for review under the FDA’s Expedited Access Pathway program. On the basis of the new study’s results, the company also filed an FDA de novo application. Baror noted his hope that the new system will be cleared for use in the United States in 2017.

It has been approved for use in Europe and is commercially available in Alzheimer’s centers there and in Asia.